Diabetes Type IIPhase 4TITRATENCT02361489
Clinical Study to Compare Various Dosing and Titration Guidelines of Insulin Delivered Via V-Go ® in Patients With Type 2 Diabetes Initiating Basal Bolus Therapy in Primary Care Offices
A Phase 4 study testing V-Go in people with Diabetes Type II, run by Valeritas, Inc. at 1 site in United States.
Trial summary
The aim of the study is to observe patients with Type 2 Diabetes on basal insulin alone or basal insulin with oral agents can be efficiently and safely started with meal time insulin using U100 rapid acting insulin analog and V-Go® Disposable Insulin Delivery Device (V-Go) using one of two dose titration algorithms to… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Diabetes Type II
- What is being tested?
- V-Go
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Age ≥ 21 and ≤80 at time of study enrollment
- Ability to read and understand English
- BMI ≥ 25 kg/m2
- Weight less than or equal to 300 pounds.
- A1C ≥8 but ≤12% (most recent value within 4 weeks of baseline visit)
- Currently using any basal insulin therapy (NPH, Levemir, Lantus) with total daily dose of 30 to 120 units, and where basal dose is greater than the patient's BMI #
- Willing to attend their physician's office for follow-up visits
- Willing and able to understand and sign a written informed consent form (ICF) indicating that they agree to participate and have been informed of all pertinent aspects of the study
- Must be willing to take and record at least 3 glucose measurements per time period (pre-breakfast, lunch, dinner and bed) per week.
- Willing to opt-in into Valeritas Customer Care so that they can receive device support and reminders throughout the study
- Most recent primary care office visit at one of the participating sites.
Exclusion Criteria:Patients presenting with any the following exclusion criteria will not be eligible for enrollment into the study:
- Patient with confirmed Type 1 diabetes and/or patients with a weight greater than 300 lbs.
- Diagnosis of an Autoimmune disease affecting metabolism
- Currently using GLP-1 medications
- Current (within the last 6 months) or planned use of insulin pump for diabetes management or the use of U500 insulin.
- Ongoing participation in any clinical study
- Pregnant, lactating or intending to become pregnant
- Current chronic systemic steroid use
- Prior V-Go use
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Geisinger
Wilkes-Barre, Pennsylvania, 18702
Amy B Cartaya,, MSHA, 570-214-9544, abcartaya@geisinger.edu
Natacha M Antunes, BS, MPH, 570-214-6985, NMANTUNES@geisinger.edu
About this study
Official title: Clinical Study to Compare Various Dosing and Titration Guidelines of Insulin Delivered Via V-Go ® in Patients With Type 2 Diabetes Initiating Basal Bolus Therapy in Primary Care Offices (Short Title: TITRATE)
The aim of the study is to observe patients with Type 2 Diabetes on basal insulin alone or basal insulin with oral agents can be efficiently and safely started with meal time insulin using U100 rapid acting insulin analog and V-Go® Disposable Insulin Delivery Device (V-Go) using one of two dose titration algorithms to achieve improved A1C at 4 months.
Read the detailed description
This study addresses the informational needs of Primary Care Physicians with regard to providing insulin dosing and titration information utilizing a V-Go disposable insulin delivery device. We look to compare two treatment arms of insulin dosing and titration in patients with Type 2 insulin-dependent diabetes - a fixed dose titration arm, and an arm where 50% of the insulin dose is given at the largest meal of the day. This study will provide practical information on glycemic control, dose requirements and safety in patients with Type 2 diabetes on basal insulin with or without oral anti-diabetic agents who are being primarily managed in the primary care office.
- Conditions
- Diabetes Type II
- Being tested
- V-Go
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-GoDevice
Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Titration Algorithm A | Active comparator | All patients that are initiated on a V-Go 20 will have a starting bolus dose of 6 clicks (12 units) during the day and all patients who are initiated on a V-Go 30 will have a starting bolus dose of 9 clicks (18 units) during the day. All patients randomized to Algorithm A will use a fixed starting dose of either 2 clicks per meal (if on the V-Go 20) or 3 clicks per meal (if on the V-Go 30). Receives: Device: V-Go |
| Titration Algorithm B | Active comparator | All patients that are initiated on a V-Go 20 will have a starting bolus dose of 6 clicks (12 units) during the day and all patients who are initiated on a V-Go 30 will have a starting bolus dose of 9 clicks (18 units) during the day. All patients randomized to Algorithm B will have 50% of their initial bolus dose given at the largest meal with less bolus insulin at the other meals as noted below: Receives: Device: V-Go |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1C
Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks).
Measured: 4 months
Secondary outcomes (6)
Change in glycemic control
- Difference in the change from baseline (randomization) to end of study visit at 4 months on glycemic control (as measured by A1C level) between the two treatment groups in a pragmatic clinical practice setting
Measured: 4 months
Patient Treatment Satisfaction
- Between-group and within-group differences (baseline to end of study visit at 4 months) in patient treatment satisfaction in adult Type 2 patient with diabetes in a real world setting
Measured: 4 months
Insulin Dose
- Total daily dose of insulin from baseline to end of study and to evaluate the between-group and within-group differences between the two dosing and titration arms
Measured: 4 months
A1c at goal
Percentage of patient achieving a A1C of ≤7%
Measured: 4 months
7 point glucose profile
Capture and analyze seven-point glucose profile at baseline and end of study
Measured: 4 months
Hypoglycemia
Rates of hypoglycemic events and utilization
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valeritas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Harris, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361489
- Sponsor's protocol ID
- CSP-029
- Acronym
- TITRATE
- Status last verified
- Feb 2015
- First submitted
- 6 Feb 2015
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Compare Various Dosing and Titration Guidelines of Insulin Delivered Via V-Go ® in Patients With Type 2 Diabetes Initiating Basal Bolus Therapy in Primary Care Offices (Short Title: TITRATE)
- ClinicalTrials.gov ID
- NCT02361489
- Acronym / sponsor ID
- TITRATE / CSP-029
- Conditions
- Diabetes Type II
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Valeritas, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to observe patients with Type 2 Diabetes on basal insulin alone or basal insulin with oral agents can be efficiently and safely started with meal time insulin using U100 rapid acting insulin analog and V-Go® Disposable Insulin Delivery Device (V-Go) using one of two dose titration algorithms to achieve improved A1C at 4 months.
Detailed description
This study addresses the informational needs of Primary Care Physicians with regard to providing insulin dosing and titration information utilizing a V-Go disposable insulin delivery device. We look to compare two treatment arms of insulin dosing and titration in patients with Type 2 insulin-dependent diabetes - a fixed dose titration arm, and an arm where 50% of the insulin dose is given at the largest meal of the day. This study will provide practical information on glycemic control, dose requirements and safety in patients with Type 2 diabetes on basal insulin with or without oral anti-diabetic agents who are being primarily managed in the primary care office.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titration Algorithm A | Active comparator | Device: V-GoAll patients that are initiated on a V-Go 20 will have a starting bolus dose of 6 clicks (12 units) during the day and all patients who are initiated on a V-Go 30 will have a starting bolus dose of 9 clicks (18 units) during the day. All patients randomized to Algorithm A will use a fixed starting dose of either 2 clicks per meal (if on the V-Go 20) or 3 clicks per meal (if on the V-Go 30). |
| Titration Algorithm B | Active comparator | Device: V-GoAll patients that are initiated on a V-Go 20 will have a starting bolus dose of 6 clicks (12 units) during the day and all patients who are initiated on a V-Go 30 will have a starting bolus dose of 9 clicks (18 units) during the day. All patients randomized to Algorithm B will have 50% of their initial bolus dose given at the largest meal with less bolus insulin at the other meals as noted below: |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-GoInitiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months. | Device | Titration Algorithm A, Titration Algorithm B |
Primary outcome
A1C
Time frame: 4 months
Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks).
6 secondary outcomes
Change in glycemic control
Time frame: 4 months
Patient Treatment Satisfaction
Time frame: 4 months
Insulin Dose
Time frame: 4 months
A1c at goal
Time frame: 4 months
7 point glucose profile
Time frame: 4 months
Hypoglycemia
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Harris, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing V-Go in people with Diabetes Type II, run by Valeritas, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karrie A Hilsinger, BA (908-927-9920 ext. 20116, khilsinger@valeritas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A1C (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.